Instructions for use

4634.01A0/C0
OR swivel stool

GA 4634.01 EN 03 2021-10-19
Copyright notice
All rights reserved.
Any duplication, adaptation or translation without prior written consent is prohibited unless otherwise provided
for in the relevant copyright laws.
© Copyright MAQUET GmbH

Subject to technical modification!

Due to further development of the product, the figures used and technical specifications given in these Instruc-
tions for Use may slightly differ from the current state of the product.

V03 02 19-10-2021

6434.01A0/C0
GA 4634.01 EN 03
 Contents

Contents
1 Introduction .............................................................................................................. 5
1.1 How to use these instructions for use................................................................................................... 5
1.1.1 Symbols and formatting ......................................................................................................... 5
1.1.2 Definitions .............................................................................................................................. 6
1.1.2.1 Design of safety notes......................................................................................... 6
1.1.2.2 Structure of notes ................................................................................................ 6
1.2 Symbols used ....................................................................................................................................... 7
1.3 Disposal ................................................................................................................................................ 8
1.3.1 Old products........................................................................................................................... 8
1.3.2 Packaging .............................................................................................................................. 8
1.4 Basic requirements ............................................................................................................................... 9
1.4.1 Use in accordance with the intended purpose ....................................................................... 9
1.4.2 Applicable standards.............................................................................................................. 9
1.4.3 Intended use .......................................................................................................................... 9
1.4.4 Types ..................................................................................................................................... 9

2 Safety notes.............................................................................................................. 10
2.1 General safety notes ............................................................................................................................ 10
2.2 Safety notes for the product ................................................................................................................. 10

3 Operation and use.................................................................................................... 12

3.1 Locking / moving the swivel stool ......................................................................................................... 12
3.2 Adjusting the height of the swivel stool................................................................................................. 13
3.3 Directions for use.................................................................................................................................. 14

4 Cleaning and disinfection ....................................................................................... 15

4.1 General information .............................................................................................................................. 15
4.1.1 No mechanical preparation .................................................................................................... 16
4.1.2 Padding.................................................................................................................................. 16
4.2 Cleaning agents and disinfectants........................................................................................................ 17
4.2.1 Suitable cleaning agents........................................................................................................ 17
4.2.2 Suitable disinfectants ............................................................................................................. 17
4.2.3 Non-usable products / substances......................................................................................... 17
4.3 Manual preparation............................................................................................................................... 18
4.3.1 Pre-cleaning........................................................................................................................... 18
4.3.2 Disinfection ............................................................................................................................ 18
4.3.3 Drying..................................................................................................................................... 18
4.3.4 Inspections............................................................................................................................. 18
4.3.5 Clean and disinfect the swivel castors. .................................................................................. 18

5 Maintenance ............................................................................................................. 19
5.1 Visual and functional inspections ......................................................................................................... 19
5.2 Maintenance ......................................................................................................................................... 20

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 Contents

5.3 Repair ................................................................................................................................................... 20

5.4 Type plate ............................................................................................................................................. 20

6 Technical specifications.......................................................................................... 21
6.1 Ambient conditions ............................................................................................................................... 21
6.2 Dimensions ........................................................................................................................................... 21
6.3 Weight .................................................................................................................................................. 21

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 Introduction
How to use these instructions for use 1

1 Introduction

1.1 How to use these instructions for use

These instructions for use are provided to familiarise you with the features of this product. The in-
structions for use are divided into separate chapters.
Please note:
• Read these instructions for use through carefully and completely before using the product for
the first time.
• Always proceed in accordance with the information provided in these instructions for use.
• Store these instructions for use in the vicinity of the product.

1.1.1 Symbols and formatting

Symbol Meaning
1. Instructions to follow / list with numbered steps
2.
Result of an action
● Numbered steps / List entry / precondition
Reference to other pages within this document
[...] Key / Module / Mode
bold Menu / on-screen button
[italics] Field to be filled in
1122.33XX Order number with different variants (XX)
Tab. 1: Symbols and formatting

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 Introduction
1 How to use these instructions for use

1.1.2 Definitions

1.1.2.1 Design of safety notes

Pictogram Descriptor Text

DANGER! Identifies an immediate danger to people, which may
result in death or serious injuries.

WARNING! Identifies a potential danger to people or property, which

may result in damage to health or serious property dam-
ages.

CAUTION! Identifies a potential danger to property, which may res-

ult in property damages.

Tab. 2: Design of safety notes

1.1.2.2 Structure of notes

Pictogram Descriptor Text

NOTE Supplementary assistance or further useful information
which does not indicate a risk of injury to persons or a
risk of property damage are described in the text of the
note.

Tab. 3: Structure of notes

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 Introduction
Symbols used 1

1.2 Symbols used

Symbols are attached to products, type plates and packaging.

Symbols Labelling
Labelling in accordance with the standard ISO 15223-1.
Symbol for "Catalogue number / product number".

Labelling in accordance with the standard ISO 15223-1.

Symbol for "Name and address of the manufacturer". The date of manufactur-
ing can be combined with this symbol.

Labelling in accordance with the ISO 15223-1 standard.

Symbol for "Consult instructions for use".

Labelling in accordance with the IEC 60601-1 standard.

Symbol for "Follow Instructions for use".

Labelling in accordance with the ISO 15223-1 standard.

Labelling of packaging materials.
Symbol for "Keep dry".

Labelling in accordance with the ISO 15223-1 standard.

Symbol for "Fragile! Handle with care".

Labelling in accordance with the ISO 7000 standard.

Symbol for "Top".

Labelling in accordance with the ISO 15223-1 standard.

Symbol for "Temperature limit".

Tab. 4: Symbols

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 Introduction
1 Disposal

Symbols Labelling
Labelling in accordance with the ISO 15223-1 standard.
Symbol for "Humidity limitation".

Labelling in accordance with the ISO 15223-1 standard.

Symbol for "Atmospheric pressure limitation".

Tab. 4: Symbols

1.3 Disposal

1.3.1 Old products

Getinge will take back used products or those which are no longer in service. For further informa-
tion, please contact your personal Getinge representative.
Used products or parts thereof may be contaminated. In order to avoid potential infection risks,
the product must be cleaned and disinfected prior to its return/disposal.
The national regulations and disposal regulations must be observed for all disposal measures.

1.3.2 Packaging
The packing materials are made of materials compatible with the environment. The packing ma-
terial may be disposed of by Getinge on request.

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 Introduction
Basic requirements 1

1.4 Basic requirements

1.4.1 Use in accordance with the intended purpose

Operation
The operator must ensure that the product is fully functional and in good working order prior to
use.

Accessories
Accessories or combinations of accessories may only be used as and when indicated in these in-
structions for use.
Other accessories, combinations of accessories or consumables may only be used if they are de-
signed specifically for the use in question and will not adversely affect either performance fea-
tures or safety requirements.

1.4.2 Applicable standards

The product has been developed and tested in accordance with medical device standards.

1.4.3 Intended use

The swivel operating stool (4634.01X0) is used as seating for the operating surgeon.
The swivel operating stool is mobile and can be locked centrally. The height is adjusted hydraul-
ically. The swivel operating stool is electrically conductive.
Any use other than described above is deemed not to be in accordance with the intended use.

1.4.4 Types
A distinction is made between the following versions:
• 4634.01A0
Round padded seat,
height adjustment of 600 - 840 mm
• 4634.01C0
Round padded seat, padded back rest
height adjustment of 600 - 840 mm

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 Safety notes
2 General safety notes

2 Safety notes

2.1 General safety notes

DA NG ER !
Potentially fatal!
Risk caused by unauthorised modifications.
Modifications at the product are not permitted.
WARN IN G !
Risk of injury!
Faulty or defective products may result in injuries.
• Before use, check the proper working order and fully functional state of the
product.
• Stop using faulty or defective products and inform the Getinge representative.
WARN IN G !
Risk of injury!
Products / accessories not attached properly may loosen and cause injuries.
Ensure that products / accessories are mounted correctly and that the securing
elements (handle screws, catches, levers, etc.) are closed and firmly tightened,
also ensure that moving parts are correctly secured.

2.2 Safety notes for the product

WARN IN G !
Risk of injury due to material failure!
The maximum permitted load for the product is 200 kg.
WARN IN G !
Risk of injury / property damage!
Danger of tipping over due to unstable position or excessive load.
Set up product on stable, horizontal surface. Observe maximum permissible load.
WARN IN G !
Risk of injury!
Do not use the product near a magnetic resonance tomograph.
CA UTIO N !
Property damage
Remove any potential hindrances before moving / adjusting the product and avoid
collisions.

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 Safety notes
Safety notes for the product 2

CA UTI ON !
Property damage caused by moving product!
When parking the product, lock the brake and check to ensure that it is properly
locked.
CA UTI ON !
Material damage!
Hold on to the product securely before relaesing the brake to prevent it from rolling
away unintentionally.

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 Operation and use
3 Locking / moving the swivel stool

3 Operation and use

3.1 Locking / moving the swivel stool

Operation is demonstrated using the swivel stool (4634.01C0) as an example.

Locking the swivel stool

1. Push the foot lever downwards on the bev-
elled side 1 .
Ø The foot lever engages.
1 Ø The foot lever is positioned up against
the base.
Ø The swivel stood is locked.

Fig. 1: Locking the swivel stool

Moving the swivel stool

1. Push against the foot lever 1 from the
front.
Ø The foot lever disengages and is
pushed upward.
Ø The swivel stool can be moved.
1

Fig. 2: Moving the swivel stool

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 Operation and use
Adjusting the height of the swivel stool 3

3.2 Adjusting the height of the swivel stool

Adjusting the swivel stool upwards
1. Fold down the pump pedal 1 and press it
several times.
Ø The seat of the swivel stool moves up-
wards.
2. Fold the pump lever back up.

Fig. 3: Adjusting the swivel stool upwards

Adjusting the swivel stool downwards

1. Place a load on the swivel stool and press
the small foot pedal 1 against the tray on
1
the stool.
Ø The seat of the swivel stool moves
slowly downwards.

Fig. 4: Adjusting the swivel stool downwards

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 Operation and use
3 Directions for use

3.3 Directions for use

Labels providing instructions for use are affixed to the product. Their meaning is explained below.

Locking the swivel stool

1. Push the foot lever downwards on the bev-
elled side 1 .

Moving the swivel stool

1. Push against the foot lever 2 from the
2 front.

Fig. 5: Locking / moving the swivel stool

Adjusting the swivel stool upwards

Fold down the pump pedal 1 and press it
several times.

Adjusting the swivel stool downwards

Place a load on the swivel stool and press the
small foot pedal 2 against the tray on the
stool.
2

Fig. 6: Adjusting the swivel stool upwards /

downwards

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 Cleaning and disinfection
General information 4

4 Cleaning and disinfection

The product must be cleaned and disinfected after each use. The product can be wiped down to
disinfect it.

4.1 General information

DA NG ER !
Risk due to mishandling of cleaning agents and disinfectants!
• The entire cleaning process may only be completed by qualified technicians.
• For information on concentration, temperature and contact and drying times,
refer to the instructions of the detergent and disinfectant manufacturer.
• Observe current national and international regulations for hygiene in the med-
ical field.
• Observe the cleaning and hygiene regulations of the hospital.
DA NG ER !
Risk of infection!
Residues on the product (e.g. blood, secretions etc.) can prevent proper dis-
infection.
• Remove coarse impurities from the product immediately with suitable non-fixing
agents.
• Adjust the cleaning agent to the disinfectant (using a combination agent if ne-
cessary) in order to avoid interactions.
DA NG ER !
Risk of infection!
Product may be contaminated.
• Always wear gloves when cleaning / disinfecting.
• If necessary, take further protective measures.
DA NG ER !
Risk of explosion!
Agents containing alcohol can form explosive vapour mixtures and ignite
where high-frequency equipment is being used. The cleaning and disinfect-
ing agents must be dried before use.
Ensure that there are no alcoholic residues on the product during high frequency
use.

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 Cleaning and disinfection
4 General information

WARN IN G !
Risk of injury!
If unsuitable cleaning agents and disinfectants are used, the antistatic prop-
erty and electrical conductivity of the product may be lost, which are re-
quired to prevent electrostatic charges as required by the standard.
Only use detergents and disinfectants of the specified active ingredient groups.
CA UTIO N !
Improper cleaning and disinfection can cause property damage!
• Observe the manufacturer's instructions for concentrations of cleaning agents
and disinfectants
• Perform visual and functional inspections after each cleaning and disinfection
process.

4.1.1 No mechanical preparation

CA UTIO N !
Property damage!
Do not use any mechanical cleaning or disinfection processes.

4.1.2 Padding

CA UTIO N !
Improper cleaning and disinfection can cause property damage!
Moisture can penetrate damaged padding. Hygiene requirements are then no
longer satisfied.
Replace damaged padding immediately.

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 Cleaning and disinfection
Cleaning agents and disinfectants 4

4.2 Cleaning agents and disinfectants

4.2.1 Suitable cleaning agents

The cleaning agents must be compatible with the disinfectants used. The use of fixing agents in
the cleaning process such as alcohols or aldehydes should be avoided.
Cleaners with the following properties may be used:
• Slightly alkaline
• Surfactants and phosphates as active cleaning components

4.2.2 Suitable disinfectants

Use only surface disinfectants with the following active ingredient bases for manual disinfection:

Ingredient group Active ingredients

Aldehydes 2-ethyl-1-hexanal, formaldehyde, glutardialdehyde, glyoxal, o-
phthaldialdehyde, succinaldehyde
Guanidine derivatives Alkyl-biguanide, chlorhexidine-digluconate, cocospropylene-diam-
ine guanidinium diacetate, oliogomeric biguanide, polyhexamethyl-
ene biguanide hydrochloride (oligo-diimino imiodo-carbonyl imino-
hexamethylene, polyhexanide)
Quaternary ammonium Alkyl-didecyl-polyoxethyl ammonium propionate, alkyl-dimethyl-al-
compounds kylbenzyl ammonium chloride, alkyl-dimethyl-ethyl ammonium
chloride, alkyl-dimethyl-ethylbenzyl ammonium chloride, benza-
lkonium propionate, benzalkonium chloride (alkyl-dimethyl-benzyl
ammonium chloride, coco-dimethyl-benzyl ammonium chloride,
lauryl-dimethyl-benzyl ammonium chloride, myristyl-dimethyl-ben-
zyl ammonium chloride), benzethonium chloride, benzyl-di-
hydroxyethyl-coco-alkyl ammonium chloride, dialkyl-dimethyl am-
monium chloride (didecyl-dimethyl ammonium chloride), didecyl-
methyl-oxyethyl ammonium propionate, mecetronium-ethyl sulfate,
methyl-benzethonium chloride, n-octyl-dimethyl-benzyl ammonium
chloride
Tab. 5: Active ingredients of disinfectants

4.2.3 Non-usable products / substances

The following products/substances must not be used for cleaning and disinfection:
• Alcohol-based agents (e.g. hand and skin disinfectants)
• Halogenides (e. g. fluorides, chlorides, bromides, iodides)
• Dehalogenating compounds (e. g. fluorine, chlorine, bromine, iodine)
• Products that scratch the surface (e.g. scouring agents, wire brushes, steel wool, cleaning
sponges containing iron)
• Standard commercial solvents (e. g. benzene, thinner)
• Water containing particles of iron
• Products containing acid (e.g. hydrochloric acid)
• Saline solutions

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 Cleaning and disinfection
4 Manual preparation

4.3 Manual preparation

CA UTIO N !
Improper cleaning can cause property damage!
Cleaning agents may not be sprayed directly into joints and cracks, and do not use
pressure / steam cleaners!
CA UTIO N !
Improper preparation can cause property damage!
Use soft, lint-free cloths to prepare the product.

4.3.1 Pre-cleaning
In case of heavy soiling it is recommended to pre-clean the product with non-fixing agents.

The following actions are to be carried out as required:

1. Remove dirt with a slightly alkaline cleaner and a soft, lint-free cloth.
2. Thoroughly clean the product with a soft, lint-free cloth moistened with pure water.

4.3.2 Disinfection
1. Select a suitable disinfectant according to the specifications.
2. Use the concentration specified by the disinfectant manufacturer for proper disinfection.
3. Thoroughly wipe the product with a soft, lint-free cloth moistened with disinfectant solution.
4. Make sure that the product is free of impurities.

4.3.3 Drying
Wipe-down disinfection does not require any drying, as excess disinfectant evaporates.
1. Observe the drying time specified by the disinfectant manufacturer.

4.3.4 Inspections
1. Carry out visual and functional inspections.

4.3.5 Clean and disinfect the swivel castors.

1. Turn the swivel castors outward.
2. Use a cloth dipped in a surface disinfectant to clean the swivel castors.

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 Maintenance
Visual and functional inspections 5

5 Maintenance

5.1 Visual and functional inspections

To ensure correct operation, it is necessary to have visual and functional inspections performed
by a trained person prior to each use.
Documentation of the results of the visual and functional inspections is recommend and should
include the date and signature of the person who performed the inspections. The following table
may be used as a template.

No. Inspection Defects are present No defects

1 Has the product not been
cleaned and disinfected in ac-
cordance with hygiene regula-
tions?
Comment:
□ 1. Do not continue to use the □
product.
2. Clean and disinfect the
product in accordance with
hygiene regulations.

2 Is it not possible to complete all □ 1. Do not continue to use the □

adjustments on the product? product.
2. Notify Getinge authorised
service.
Comment:

3 Are there damages to mechan- □ 1. Do not continue to use the □

ical parts? product.
2. Notify Getinge authorised
service.
Comment:

4 Is turning the swivel castors im- □ 1. Do not continue to use the □

possible? product.
2. Inform service personnel.
Comment:

5 (Space for other tests) □ 1. □

Comment:

Tab. 6: Visual and functional inspections

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 Maintenance
5 Maintenance

5.2 Maintenance
This product is maintenance-free.
Wear caused by use and age may influence the safety-relevant functions of the product.
Check the state of the product prior to each use.
If defects are discovered, do not continue to use the product.
Inform the relevant Getinge representative for repairs.

5.3 Repair
A damaged product may not be used and you may not repair it yourself. Please have the follow-
ing information at hand for your Getinge representative:
• Description of the defect
• Product number (see type plate)
• If available: Serial number (see type plate)
• Construction year (see type plate)
Hotline for Germany: +49 (0) 180 32 12 144
Hotlines for other countries can be found at www.getinge.com.

5.4 Type plate

Position of the type plate 1 on the product.

Fig. 7: Type plate position

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 Technical specifications
Ambient conditions 6

6 Technical specifications

NO TE
For dimensions, adjustment ranges and weight specifications, there is a tolerance
of ±5 %, if no other tolerance is specified.

6.1 Ambient conditions

Temperature: Shipping / storage -20 °C to +50 °C
Temperature: Operation +10 °C to +40 °C
Relative humidity: Shipping / storage 10 % to 95 %
Relative humidity: Operation 30 % to 75 %
(non-condensing)
Atmospheric pressure: Shipping / storage 500 hPa to 1060 hPa
Atmospheric pressure: Operation 700 hPa to 1060 hPa

6.2 Dimensions
Seat surface diameter 350 mm
Diameter of castors 50 mm

6.3 Weight
Net weight 38 kg

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MAQUET GmbH · Kehler Str. 31 · 76437 Rastatt · GERMANY · Phone: +49 7222 932 -0

www.getinge.com
GA 4634.01 EN 03 2021-10-19